Function as marketing authorisation holder
In addition to classic pharma consulting, Diapharm offers clients another exclusive service. We assume all the duties and responsibilities of a GMP-compliant marketing authorisation holder for you, either for a specific period of time or long-term, depending on your needs.
This service, which is offered in addition to medical and pharma consulting, is ideal for all manufacturers and pharmaceutical companies launching new products which:
- need a comprehensive Good Manufacturing Practice (GMP) compliant quality management system and pharmacovigilance system without delay
- want to apply for marketing authorisation procedures, particularly mutual recognition procedures (MRP) and decentralised procedures (DCP) easily using an external marketing authorisation holder
- would like to get attractive submission periods (time slots) from regulatory authorities in the European Union
- want to market medicinal products and investigational medicinal products in the European Union as manufacturers from non-EU member states (Switzerland, United States, etc)
- want to handle medicinal product acquisitions, sales or co-marketing agreements confidentially through a 3rd party
Being a pharmaceutical company as defined by the EU legislation, Diapharm is equipped to handle these responsibilities. For example, we are certified acc. to GMP (Good Manufacturing Practice). Depending on your individual needs, our medical and pharma consulting specialists also coordinate the assumption of the duties and responsibilities of the qualified person for pharmacovigilance, information officer or qualified person, as stipulated in the German Drug Law.
